LT3001 Safety and Drug Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, LT3001, to evaluate its effects when combined with common medications like aspirin and clopidogrel. The primary goal is to ensure LT3001's safety and understand its behavior in the body. Healthy individuals who do not smoke or have bleeding issues may qualify for this study. Participants will receive LT3001 either alone or with other drugs, while some will receive a placebo (a harmless pill resembling the drug) for comparison. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it is designed to study drug interactions, so you might need to discuss your medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that LT3001 has been tested for safety in people who have had a stroke. Studies found that most participants tolerated the drug well, experiencing no serious side effects. These studies also examined how LT3001 interacts with other common medications, such as aspirin, clopidogrel, and blood thinners like apixaban and dabigatran.
No major safety problems emerged in these studies. The trials aimed to understand how LT3001 behaves in the body and whether it causes any issues when used with other drugs. This past research supports the safety of LT3001, but careful consideration is important before joining any trial. Always consult a doctor before deciding to participate in a clinical trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about LT3001 because it offers a fresh approach to treating conditions typically managed by blood thinners like aspirin, clopidogrel, apixaban, and dabigatran. Unlike these standard treatments, LT3001 is designed to be administered intravenously, which could allow for more precise control over the dosage and potentially quicker onset of action. Additionally, LT3001 may work through a unique mechanism, offering a new way to influence blood clotting processes. This could open doors to improved safety profiles and effectiveness, especially for patients who need a different option than what's currently available.
What evidence suggests that this trial's treatments could be effective?
Research has shown that LT3001 may aid stroke patients in recovery. In one study, 90 days after treatment, patients who received LT3001 were 7.3% more likely to live independently compared to those who did not receive it. Another study found that 21.4% of patients treated with LT3001 experienced excellent recovery, with little to no disability. Additionally, nearly half of the patients showed significant neurological improvement within 30 days. This trial will evaluate LT3001 in combination with medications such as Aspirin, Clopidogrel, Apixaban, and Dabigatran to assess its effectiveness in aiding stroke recovery.12678
Who Is on the Research Team?
Mimi Yeh, PhD
Principal Investigator
Lumosa Phase 1 unit
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Double-blind, placebo-controlled phase to examine the safety and PK profiles of multiple doses of LT3001
Treatment Part B
Open-label phase to assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban, or dabigatran
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LT3001 drug product
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lumosa Therapeutics Co., Ltd.
Lead Sponsor